Reflexology for Chronic Constipation

NCT01599156 | Unknown Phase 2

• 1 other identifier: REF11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.

Conditions

Chronic Constipation

Keywords

Chronic constipation; Reflexology; Complementary medicine

Outcome Measures

Primary Outcomes (2)

• Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks

  Will be assessed daily during the 24 weeks of the study

  24 weeks

• Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period

  Will be assessed weekly during the 24 weeks of the study

  24 weeks

Secondary Outcomes (10)

• Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)

  24 weeks

• Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period

  24 weeks

• Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).

  24 weeks

• Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)

  24 weeks

• Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)

  24 weeks

Study Arms (1)

Reflexology

EXPERIMENTAL

reflexology treatment, x2-3/week for 12 weeks

Procedure: Reflexology

Interventions

Reflexology PROCEDURE

Reflexology is a therapy whereby diagnosis and treatment are done on the patient's feet. According to reflexology, our feet are a micro-cosmos of our bodies and contain all the body's systems and internal organs. The treatment is palpation and massage of specific reflex points that respond to the body organs. This massage or palpitation of reflex points improves the physical function of the corresponding organ or system

Reflexology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-55 years
• Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
• One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
• Ability to comply with the study guidelines

You may not qualify if:

• Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
• Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
• Rome III criteria for the irritable bowel syndrome.
• History of pelvic-floor dysfunction.
• Neurological pathologies
• Psychiatric conditions
• Chronic use of medication with a GI-activity.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Menachem Oberbaum, MD

  Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il

  PRINCIPAL INVESTIGATOR

• Joseph Lysy

  Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Menachem Oberbaum, MD

CONTACT

+972-2-6666395; oberbaum@szmc.org.il

Joseph Lysy, MD

CONTACT

+972-2-6666116; lysyj@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 15, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2012-07

Locations

IL (1)